Post Operative Pain in Cerebral Palsy Level: LLT Classification code 10054710 Term: Post Operative Hip Pain Level: LLT Classification code 10008129 Term: Cerebral Palsy
Conditions
Interventions
Trade Name: BOTOX
Product Name: Botox
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Protein complex derived from Clostridi
Sponsors
Guys and St Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The child has displaced hips requiring bony orthopaedic surgery (osteotomy) due to cerebral palsy. 2. The child is between the ages of 2 and 18 years. 3. The child has a GMFCS level of IV or V 4. The child has a diagnosis of hypertonic cerebral palsy (or a diagnosis consistent with this nomenclature) 5. The child does not communicate verbally 6. Informed consent to participate has been given by parent/carer. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. The child is younger than 2 years or older than 18 years 2. The child has an acute and current systemic infection or illness 3. The child has had botulinum toxin injections within the past 4 months 4. The child has had a previous reaction to botulinum toxin 5. The child has received or is likely to receive, at the time of trial drug or placebo administration, medications which might interact with botulinum toxin (this does not apply to any drugs at present) 6. Insufficient understanding of the trial by the parent or carer, in the investigator’s opinion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Secondary outcome measures: length of stay, return to school, tolerance of sitting,transfusion requirements and quality of life. We will collect information on pain throughout the course of the study which will generate a comprehensive description of the patient's pain experience. ;Primary end point(s): Change in pain score during the six weeks following the operation; Main Objective: To assess the benefit to children with cerebral palsy of having botulinum toxin injections prior to major hip surgery, in order to reduce their post-operative pain. To describe the pain experience of children with cerebral palsy undergoing major hip surgery. | — |
Countries
United Kingdom
Outcome results
None listed